Events

Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2014-RN-00962-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-09-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00962-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has identified two scenarios in which the mckesson cardiology hemo calculation section incorrectly converts the haemoglobin value before it is utilized in the applicable formula calculations. as a result, the formula output is incorrect. if the issue occurs, then for those procedures that use the specified formula calculations, the formula outputs will be incorrect. this may lead to delay in appropriate treatment or incorrecttreatment.
  • 조치
    McKesson will provide a resolution to this issue through a software update. A system check will also take place to identify any previous procedure calculations that may have been affected in your facility. Until the correction is completed additional procedures to ensure correct Hb values are requested to be carried out by end users. This action has been closed-out on 07/06/2016.

Device

Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system)
  • 모델명 / 제조번호(시리얼번호)
    Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system)ARTG Number: 146573
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd